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Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Sponsor: Children's Oncology Group · NCT01790152 on ClinicalTrials.gov ↗

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Conditions studied

Hodgkin Lymphoma in RemissionLeukemia in RemissionLymphoblastic LymphomaOsteosarcomaRecurrent LeukemiaRecurrent LymphomaRecurrent Malignant Neoplasm

What it tests

  • Assessment of Therapy Complicationsother
  • Laboratory Biomarker Analysisother
  • Quality-of-Life Assessmentother
  • Questionnaire Administrationother

Where it's running79 sites

  • Children's Hospital of Alabama

    Birmingham, Alabama 35233

    Recruiting now

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016

    Recruiting now
    • Site Public Contact(contact)602-546-0920
    • Alexandra M. Walsh(principal investigator)

  • Banner University Medical Center - Tucson

    Tucson, Arizona 85719

    Recruiting now

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591

    Recruiting now
    • Site Public Contact(contact)501-364-7373
    • David L. Becton(principal investigator)

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010

    Recruiting now

  • Valley Children's Hospital

    Madera, California 93636

    Active, not recruiting

  • Kaiser Permanente-Oakland

    Oakland, California 94611

    Recruiting now

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California 94304

    Recruiting now

  • Rady Children's Hospital - San Diego

    San Diego, California 92123

    Recruiting now
    • Site Public Contact(contact)858-966-5934
    • William D. Roberts(principal investigator)

  • Yale University

    New Haven, Connecticut 06520

    Recruiting now

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908

    Recruiting now

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida 32610

    Suspended

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021

    Active, not recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida 32207

    Recruiting now
    • Site Public Contact(contact)904-697-3529
    • Ramamoorthy Nagasubramanian(principal investigator)

  • Nemours Children's Hospital

    Orlando, Florida 32827

    Recruiting now
    • Site Public Contact(contact)407-650-7150
    • Ramamoorthy Nagasubramanian(principal investigator)

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida 33701

    Active, not recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida 33607

    Recruiting now

  • Saint Mary's Hospital

    West Palm Beach, Florida 33407

    Recruiting now
    • Site Public Contact(contact)561-881-2815
    • Narayana Gowda(principal investigator)

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322

    Recruiting now

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813

    Active, not recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826

    Recruiting now
    • Site Public Contact(contact)808-983-6090
    • Wade T. Kyono(principal investigator)

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois 60611

    Recruiting now
    • Site Public Contact(contact)773-880-4562
    • Jennifer L. Reichek(principal investigator)

  • University of Illinois

    Chicago, Illinois 60612

    Active, not recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois 60453

    Recruiting now
    • Site Public Contact(contact)847-723-7570
    • Rebecca E. McFall(principal investigator)

  • Saint Jude Midwest Affiliate

    Peoria, Illinois 61637

    Recruiting now
    • Site Public Contact(contact)888-226-4343
    • Jaime M. Libes(principal investigator)

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana 70121

    Recruiting now

  • Maine Children's Cancer Program

    Scarborough, Maine 04074

    Recruiting now

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215

    Recruiting now

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland 21287

    Recruiting now

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215

    Recruiting now
    • Site Public Contact(contact)877-442-3324
    • Lynda M. Vrooman(principal investigator)

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan 48201

    Active, not recruiting

  • Ascension Saint John Hospital

    Detroit, Michigan 48236

    Recruiting now

  • Hurley Medical Center

    Flint, Michigan 48503

    Active, not recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216

    Recruiting now
    • Site Public Contact(contact)601-815-6700
    • Anderson (Andy) B. Collier(principal investigator)

  • Columbia Regional

    Columbia, Missouri 65201

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri 63110

    Recruiting now

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102

    Recruiting now

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada 89109

    Recruiting now

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada 89135

    Recruiting now

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada 89144

    Recruiting now

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756

    Active, not recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601

    Recruiting now
    • Site Public Contact(contact)201-996-2879
    • Michael B. Harris(principal investigator)

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87102

    Recruiting now

  • Roswell Park Cancer Institute

    Buffalo, New York 14263

    Suspended

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York 11040

    Recruiting now
    • Site Public Contact(contact)718-470-3460
    • Jonathan D. Fish(principal investigator)

  • University of Rochester

    Rochester, New York 14642

    Recruiting now
    • Site Public Contact(contact)585-275-5830
    • Angela R. Girvin(principal investigator)

  • Stony Brook University Medical Center

    Stony Brook, New York 11794

    Recruiting now
    • Site Public Contact(contact)800-862-2215
    • Laura E. Hogan(principal investigator)

  • State University of New York Upstate Medical University

    Syracuse, New York 13210

    Recruiting now
    • Site Public Contact(contact)315-464-5476
    • Philip M. Monteleone(principal investigator)

  • Mission Hospital

    Asheville, North Carolina 28801

    Recruiting now

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157

    Recruiting now
    • Site Public Contact(contact)336-713-6771
    • Thomas B. Russell(principal investigator)

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308

    Recruiting now
    • Site Public Contact(contact)330-543-3193
    • Steven J. Kuerbitz(principal investigator)

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229

    Recruiting now

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104

    Recruiting now

  • Legacy Emanuel Children's Hospital

    Portland, Oregon 97227

    Recruiting now
    • Site Public Contact(contact)503-413-2560
    • Janice F. Olson(principal investigator)

  • Oregon Health and Science University

    Portland, Oregon 97239

    Recruiting now

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania 19134

    Recruiting now
    • Site Public Contact(contact)215-427-8991
    • Gregory E. Halligan(principal investigator)

  • Rhode Island Hospital

    Providence, Rhode Island 02903

    Recruiting now
    • Site Public Contact(contact)401-444-1488
    • Jennifer J. Greene Welch(principal investigator)

  • Medical University of South Carolina

    Charleston, South Carolina 29425

    Recruiting now

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina 29605

    Recruiting now

  • Medical City Dallas Hospital

    Dallas, Texas 75230

    Active, not recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas 75390

    Recruiting now

  • Cook Children's Medical Center

    Fort Worth, Texas 76104

    Suspended

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas 77030

    Recruiting now

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229

    Recruiting now

  • University of Vermont and State Agricultural College

    Burlington, Vermont 05405

    Recruiting now

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298

    Recruiting now

  • Seattle Children's Hospital

    Seattle, Washington 98105

    Recruiting now
    • Site Public Contact(contact)866-987-2000
    • Douglas S. Hawkins(principal investigator)

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204

    Recruiting now

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226

    Recruiting now
10 international sites

  • Princess Margaret Hospital for Children

    Perth, Western Australia, Australia 6008

    Active, not recruiting

  • Perth Children's Hospital

    Perth, Western Australia, Australia 6009

    Recruiting now
    • Site Public Contact(contact)[email protected]
    • Marianne B. Phillips(principal investigator)

  • Alberta Children's Hospital

    Calgary, Alberta, Canada T3B 6A8

    Recruiting now

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, Canada L8N 3Z5

    Suspended

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, Canada K1H 8L1

    Active, not recruiting

  • Hospital for Sick Children

    Toronto, Ontario, Canada M5G 1X8

    Suspended

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, Canada H3H 1P3

    Recruiting now

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, Canada H3T 1C5

    Recruiting now
    • Site Public Contact(contact)514-345-4931
    • Yvan Samson(principal investigator)

  • Centre Hospitalier Universitaire de Quebec

    Québec, Canada G1V 4G2

    Recruiting now
    • Site Public Contact(contact)418-525-4444
    • Bruno Michon(principal investigator)

  • San Jorge Children's Hospital

    San Juan, Puerto Rico 00912

    Recruiting now
    • Site Public Contact(contact)787-727-1000
    • Luis A. Clavell(principal investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

Study Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV

* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS
* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)
* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia/lymphoblastic lymphoma \[P9404, high-risk DFCI 95-01\] or Hodgkin lymphoma \[P9425/P9426\])
* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation
* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \[also includes fields directed towards the neck, upper abdomen, or spine\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible
* STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \[COG?s\] Statistics and Data Center \[SDC\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)
* STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis
* STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM III: OSTEOSARCOMA SURVIVORS
* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and/or parents/legal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors
* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:

  * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible
  * \< 31 years of age at time of initial osteosarcoma diagnosis
  * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002
  * No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis
  * Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria
  * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies
  * No exposure to DRZ at any point in time
  * All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and/or radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year
* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \[DICOM\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable
* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)
* Based on echocardiography, must have either left ventricular fractional shortening =\< 28.0% or ejection fraction =\< 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection
* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \[ACE\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months
* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Updated 2026-05-18 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.